Who To Contact
Baptist MD Anderson
Cancer Center
1301 Palm Avenue
Jacksonville, FL 32207
Poonam K. Neki, MBBS,DA, CCRP
Research Director
Baptist MD Anderson Clinical Trials
904.202.7468
poonam.neki@bmcjax.com
Clinical Trial ID: NCT99999999
The Spiration IBV Valve System
Status
Open
Description
The Spiration IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to six weeks per prolonged air leak.
Objective
The Spiration IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).
Treatment
TABLE 1: IBV Valve Biocompatibility Testing and Results TABLE 2: Deployment Catheter Biocompatibility Testing and Results
Conditions
Other
Age Group
Adult
Main Investiagtor
Modi, Aakash
Practice
Lung
Scope
National
Participating Institutions
Baptist MD Anderson Cancer Center
Eligibility
Directions for use: See the Physician's Labeling. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions and Adverse Events in the labeling. Postapproval Requirements and Restrictions: See Approval Order.
Nct ID Number
NCT99999999
Secondary Trial ID Number
H060002/Spiration IBV Valve
Keywords
Humanitarian Device